Significance of Contralateral Central Lymph Node Dissection in Unilateral cN0 Differentiated Thyroid Carcinoma.

NCT03845647 | Unknown

• 1 other identifier: ZDWY.JRWK.002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

There are so many contradictions over central lymph node dissection in unilateral cN0(Clinically N0) differentiated thyroid carcinoma.In order to provides a new theoretical basis for the operation of central lymph node in cN0(Clinically N0) differentiated thyroid cancer,researchers are going to complete this study to evaluate the significance of contralateral central lymph node dissection in unilateral cN0(Clinically N0) differentiated thyroid carcinoma.At the same time,it may play a certain impact on the revision of surgical guidelines for differentiated thyroid cancer.

Conditions

Lymph Node Dissection; Lymph Node Metastases; Differentiated Thyroid Carcinoma

Keywords

lymph node dissection; differentiated thyroid carcinoma

Outcome Measures

Primary Outcomes (3)

• Tumor diameter

  Tumor diameter will be measured by postoperative pathological examination.

  12 months

• Number of lymph nodes dissected in every side of central lymph node

  Count the number of lymph nodes dissected during operation in every side of central lymph nodes of every Participants.

  12 months

• Number of metastatic lymph nodes diagnosed by Postoperative pathology

  Count the number of metastatic lymph nodes diagnosed by Postoperative pathology in every side of central lymph nodes of every Participants.

  12 months

Secondary Outcomes (1)

• Rate of lymph nodes metastasis

  12 months

Study Arms (2)

Tumor diameter<=2cm study group

EXPERIMENTAL

In order to provides a new theoretical basis for the operation of central lymph node in cN0 differentiated thyroid cancer,researchers are going to complete this study to evaluate the significance of contralateral central lymph node dissection in unilateral cN0 differentiated thyroid carcinoma.At the same time,it may play a certain impact on the revision of surgical guidelines for differentiated thyroid cancer.

Procedure: contralateral central lymph node dissection

Tumor diameter>2cm study group

EXPERIMENTAL

In order to provides a new theoretical basis for the operation of central lymph node in cN0(Clinically N0) differentiated thyroid cancer,researchers are going to complete this study to evaluate the significance of contralateral central lymph node dissection in unilateral cN0 differentiated thyroid carcinoma.At the same time,it may play a certain impact on the revision of surgical guidelines for differentiated thyroid cancer.

Procedure: contralateral central lymph node dissection

Interventions

contralateral central lymph node dissection PROCEDURE

contralateral central lymph node dissection

Tumor diameter<=2cm study group; Tumor diameter>2cm study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accurately diagnosing primary differentiated thyroid carcinoma according to pathological diagnostic criteria .
• Differentiated thyroid carcinoma with cN0(Clinically N0) was diagnosed by thyroid ultrasound text and/or neck CT,and was confirmed with differentiated thyroid carcinoma by postoperative pathological examination.
• The age is more than 18 years old and less than 65 years old. There is no gender restriction.
• Untreated patients who have not received surgery, interventional therapy,chemotherapy, biotherapy, and radiation therapy.
• Physical condition score of Eastern Cooperative Oncology Group（ECOG）: 0-2; no major organ dysfunction; oxygen partial pressure ≥ 10.64 kilopascal（kPa）; white blood cell count≥ 4 × 109/ L; hemoglobin≥ 9.5g/dL; neutrophil absolute count ≥ 1.5 × 109 / L; platelet count ≥ 100× 109 / L; total bilirubin ≤ 1.5 times of the upper limit of normal value;creatinine ≤ 1.25 times of the upper limit of normal value; and creatinine clearance ≥ 60ml / min.
• Be able to obtain complete follow-up information, understand the situation of this study and sign informed consent.

You may not qualify if:

• ①Bilateral DTC(differentiated thyroid cancer) patients ②Non-DTC(differentiated thyroid cancer)patients ③ Non-cn0(Clinically N0) patients ④ cN0(Clinically N0) patients but could not be operated on.
• Poorly controlled diabetics (fasting blood glucose levels \> 200 mg/dL). In addition to four types of malignant tumors that can be treated with radical resection, such as cervical cancer in situ, basal or squamous cell skin cancer, (breast) ductal carcinoma in situ, and organ localized prostate cancer, suffering from any other malignant tumors within 5 years.• Breastfeeding and/or pregnant women.
• Patients with severe bleeding tendencies (prothrombin time less than 50%,cannot be corrected by treatment with vitamin K, etc.).
• Recent severe hemoptysis, severe cough, dyspnea or patients are not able to cooperate.
• People with severe emphysema, pulmonary congestion, and pulmonary heart disease.
• Researchers believe that the subject may not be able to complete this study or may not be able to comply with the requirements of this study (for management reasons or other reasons).

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Fifth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qingan Zeng, doctor

CONTACT

0756-2528810; zengqa1218@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2019
• First Posted: February 19, 2019
• Study Start: February 1, 2019
• Primary Completion: December 28, 2020
• Study Completion: December 28, 2020
• Last Updated: November 24, 2020

Record last verified: 2019-11

Locations

CN (1)